Phase 2
N=45
Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection
Myeloma · Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01095757 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis — 9; 17 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plerixafor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients Achieving Greater Than or Equal to 5 x 10^6 of CD34+ Cells/kg in a Single Day of Apheresis |
9; 17 | — |
| PRIMARY Patients Achieving >= 3 X 10^6 CD34+ Cell/Kg |
10; 23 | — |
| SECONDARY Average Number of Days for Engraftment (Engraftment Defined as Absolute Neutrophil Count>500) |
12.4; 12.105 | — |
Summary
The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor.
The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.
Eligibility Criteria
Inclusion Criteria
- Age 18-70 years
- Multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL) patients in first or second complete or partial remission
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Up to 3 prior treatment regimens
- Meet all eligibility requirements for autologous transplant
- Adequate marrow function defined as white blood cells (WBC) >3,000; ANC >1,500/mm3; platelets >75,000/mm3
- Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault
- Adequate liver function defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin 38°C
- Weight > 175% of ideal body weight as defined by the Devine equation
- Experimental therapy within 4 weeks
- Cytokine administration in the previous 14 days
Data sourced from ClinicalTrials.gov (NCT01095757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.